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CTRI Number  CTRI/2012/03/002477 [Registered on: 05/03/2012] Trial Registered Prospectively
Last Modified On: 29/11/2012
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A clinical trial to study the effect of cough mixture syrup of levosalbutamol, ambroxol and guaiphenesin in the treatment of patients suffering from productive cough associated with acute bronchitis.  
Scientific Title of Study   A randomized, double blind, placebo controlled, prospective, multicentre, two arm, parallel study to assess efficacy, safety and tolerability of cough mixture of Levosalbutamol Sulphate 0.5 mg, Ambroxol Hydrochloride 15 mg and Guaiphenesin 50 mg per 5ml syrup in the symptomatic treatment of patients suffering from productive cough associated with acute bronchitis.  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
GL-AB/2011-12, version no. 1.0, dated:13.06.2011  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name   
Designation   
Affiliation   
Address 




 
Phone    
Fax    
Email    
 
Details of Contact Person
Scientific Query  
Name  Dr Piyush Agarwal 
Designation  Deputy General Manager 
Affiliation  Glenmark Pharmaceuticals Ltd 
Address  Glenmark Pharmaceuticals Ltd Glenmark House, B D Sawant Marg Chakala, Andheri(East)

Mumbai
MAHARASHTRA
400099
India 
Phone  912240189999  
Fax    
Email  piyusha@glenmarkpharma.com  
 
Details of Contact Person
Public Query  
Name  Dr Shailendra Sachan 
Designation  Manager-Clinical Research 
Affiliation  Glenmark Pharmaceuticals Ltd 
Address  Glenmark Pharmaceuticals Ltd Glenmark Research Centre, Plot No. A-607, T.T.C. Industrial Area, MIDC, Mahape, Navi Mumbai

Mumbai
MAHARASHTRA
400709
India 
Phone  912267720000  
Fax    
Email  shailendrasachan@glenmarkpharma.com  
 
Source of Monetary or Material Support  
Glenmark Pharmaceuticals Ltd. 
 
Primary Sponsor  
Name  Glenmark Pharmaceuticals Ltd 
Address  Glenmark Pharmaceuticals Ltd. Glenmark House, B D Sawant Marg Chakala, Andheri(East), Mumbai, India-400 099  
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 11  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr S Sreenivas  Dayal Clinic  Dayal Clinic Department of General Medicine 43-18-21/A, T.S.N. Colony, Opposite Hero Honda Showroom, Dondaparthy Visakhapatnam
Visakhapatnam
ANDHRA PRADESH 		 08912745490

s.sreenivaas3@gmail.com 
Dr B L N Prasad  King George Hospital  King George Hospital Department of General Medicine Visakhapatnam 530002
Visakhapatnam
ANDHRA PRADESH 		 09848211931

amcmedicine@hotmail.com 
Dr Shankar Kumar  M. S. Diabetes & Shirdi Skin Care Center  M. S. Diabetes & Shirdi Skin Care Center Department of General Medicine 6/1, Opp. Krishna Sagar Hotel, 80 Feet Road, Indira Nagar, Bangalore
Bangalore
KARNATAKA 		 08041161176

drleelaskincare@rediffmail.com 
Dr A Venkateshwar Rao  Medimart Clinic & Pharmacy  Medimart Clinic & Pharmacy Department of General Medicine Saibaba Temple Road, Beside Reliance Fresh Dilsukhnagar, Hyderabad
Hyderabad
ANDHRA PRADESH 		 09440040662

venky_gmc@yahoo.co.in 
Dr R K Panda  Pt. J. N. M Medical College  Pt. J. N. M Medical College Department of Chest and TB Raipur, Chattisgarh – 492001
Raipur
CHHATTISGARH 		 919425525213

rkpanda_dr@yahoo.com 
Dr B Rama Chandra Rao  RC ENT Clinic  RC ENT Clinic, Department of General Medicine Kalyanarama Complex, Opp. Sagar lodge, Collectorate jn, Visakhapatnam- 530002
Visakhapatnam
ANDHRA PRADESH 		 919848498488

drramachandraent@gmail.com 
Dr A Krishna Murthy  Sai Chatanya Clinic  Sai Chaitanya Clinic, Department of General Medicine Opp KGH clock tower, D.no:17-1-26, Maharanipeta, Visakhapatnam
Visakhapatnam
ANDHRA PRADESH 		 09866234267

drkrishnamurthy.a@gmail.com 
Dr Balachandra Giriappa  Sapthagiri Institute of Medical Science  Sapthagiri Institute of Medical Science Department of General Medicine #15 Chikkasandra, Hesaragatta Main Road, Bangalore – 560 090
Bangalore
KARNATAKA 		 919845111559

drgbalachandra@gmail.com 
Dr S Dinesh  Seventh Day Adventist Medical Center  Seventh Day Adventist Medical Center Department of General Medicine #8, Spencer Road, Frazer Town Bangalore – 560005 Karnataka
Bangalore
KARNATAKA 		 08041688587

bhaktha.dinesh@gmail.com 
Dr Srinivas Kulkarni  Sri Clinic  Sri Clinic Department of General Medicine 3-4-206/2, Opposite Mahankali Temple, Lingampalli, Kachiguda, Hyderabad
Hyderabad
ANDHRA PRADESH 		 09603156396

srinivaskulkarni_dr@rediffmail.com 
Dr Vinay Kumar  Surya Chest Clinic  Surya Chest Clinic Department of Pulmonology Near Bhoom Reddy Hospital, Civil Hospital Road, Karimnagar, Andhra Pradesh – 505001
Karimnagar
ANDHRA PRADESH 		 919866064520

dr.vinay.mdc@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 11  
Name of Committee  Approval Status 
Clinicom, Bangalore Asha Health Pitstop, Bangalore  Submittted/Under Review 
Clinicom, Bangalore M. S. Diabetes & Shirdi Skin Care Center, Bangalore  Submittted/Under Review 
Institutional Ethics Committee, Sapthagiri Institute of Medical Science, Bangalore   Submittted/Under Review 
Mittal Institute of Medical Science, Indore Vaibhavi Chest Clinic  Submittted/Under Review 
Virtuous Independent Ethics Committee, Hyderabad Medimart Clinic & Pharmacy, Hyderabad  Submittted/Under Review 
Virtuous Independent Ethics Committee, Hyderabad Sri Clinic, Hyderabad   Submittted/Under Review 
Virtuous Independent Ethics Committee, Hyderabad Surya Chest Clinic  Submittted/Under Review 
VZ Human Research Protection Care Dayal Clinic, Visakhapatnam  Approved 
VZ Human Research Protection Care Imma Labs, Visakhapatnam  Approved 
VZ Human Research Protection Care RC ENT Clinic  Approved 
VZ Human Research Protection Care, Visakhapatnam Sai Chatanya Clinic, Visakhapatnam  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Productive Cough Associated with Acute Bronchitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Levosalbutamol Sulphate 0.5mg, Ambroxol Hydrochloride 15mg and Guaiphenesin 50mg per 5 ml syrup  The dose is 10 ml of the syrup three times a day for eight days 
Comparator Agent  Placebo syrup  The dose is 10 ml of the syrup three times a day for eight days.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Male or female ≥18 to <60 years and willing to give their written informed consent.

2. Patients with a recent onset of < or equal to 2 days of bronchial mucus production with impaired ability to cough up, and a baseline Bronchial Severity Score (BSS) of ≥5 score points out of a maximum of 20 points

3. Patients willing to comply with the protocol requirements.
 
 
ExclusionCriteria 
Details  1. Pregnant or lactating women.
2. Patient with known hypersensitivity to any of the components of the formulation.
3. Female patients of child bearing potential who do not agree to remain abstinent or use medically acceptable methods of contraception during the study therapy and for 4 weeks after the end of study therapy.
4. Patient with alcohol or drug dependence.
5. Patient with a history of clinically relevant chronic cardiovascular, kidney, gastrointestinal or liver disease.
6. Patients with antibiotic use in the preceding 2 weeks
7. Patients with a concurrent infection including Tuberculosis (TB) requiring antibiotic treatment.
8. Patients with malignant growth or any severe somatopathic, neurologic and / or psychiatric disease.
9. Patient who has clinical laboratory evaluations (including biochemistry, hematology, and complete urinalysis) that are not within the reference range for the testing laboratory at screening and the results are deemed clinically significant by the investigator
10. Patients who have participated in any clinical trial in the past 1 month
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Ease of Cough and Clearance of Sputum  8-days 
 
Secondary Outcome  
Outcome  TimePoints 
1. Improvement in Breathlessness   8-days 
2. Reduction in Sputum Volume  8-days 
3. Decrease in Consistency of Sputum   8-days 
4. Change in mean Bronchial Severity Score  8-days 
5. Change in Patient’s General Well being  8-days 
 
Target Sample Size   Total Sample Size="260"
Sample Size from India="260" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)
Modification(s)  		 01/11/2012 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="5"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Other (Terminated) 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

This is double-blind, randomized, placebo controlled, two-arm, parallel-group, comparative study. The study will be conducted in patients suffering from productive cough associated with acute bronchitis. Study will enroll 260 patients across different centers from India.

Patients will be recruited after providing written informed consent. After screening, patients will be randomized (meeting all inclusion/exclusion criteria) in 1:1 ratio to receive either mixture of Levosalbutamol Sulphate, Ambroxol Hydrochloride and Guaiphenesin syrup or placebo syrup for eight days.

The primary objective of the study is to see the ease of cough and clearance of sputum. Secondary objective includes improvement in breathlessness, reduction in sputum volume, decrease in consistency of sputum, change in mean bronchial severity score, change in patient’s general well being and safety evaluation.

During the study, there will be 3 study visits at day 0, day 3 and day 8 for efficacy, safety and tolerability assessment.  
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